Recall Z-1777-2008 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.
| Date | Aug 27, 2008 (initiated Apr 28, 2008) |
| Status | Terminated |
| Reason | A risk of entrapment will exist between the head and foot rails if installation instructions are followed. |
| Root cause | Other |
| Action | Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist. |
| Quantity | 69 |
| Distribution | Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.